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. Author manuscript; available in PMC: 2011 Jul 4.
Published in final edited form as: J Cardiovasc Electrophysiol. 2009 Jul 1;20(9):982–987. doi: 10.1111/j.1540-8167.2009.01503.x

Table 2.

Exclusions

Exclusion Criteria
  1. History of cardiac arrest or spontaneous or inducible sustained VT (15 beats or more at a rate of 120 BPM or greater).

  2. Unexplained syncope

  3. Expected revascularization based on investigator’s clinical assessment within the next 12 months (patients may be reevaluated 90 days after revascularization).

  4. Currently implanted permanent pacemaker and/or pacemaker/ICD lead

  5. Recent MI (<40 days) or revascularization (<90 days)

  6. CVA within 90 days

  7. Antiarrhythmics drug therapy for ventricular arrhythmias

  8. New York Heart Association CHF functional class IV at enrollment

  9. Pregnancy

  10. Any condition other than cardiac disease that, in the investigator’s judgment, would seriously limit life expectancy (poor 6-month survival)

  11. Contraindication to a ICD implant (i.e. inadequate venous access, bleeding disorder)

  12. Marked valvular heart disease requiring surgical intervention

  13. Current alcohol or drug abuse

  14. Participating in other trials with an active treatment arm (not to exclude patients who are in trials of diagnostic techniques or approved therapies)

  15. Unwilling or unable to provide informed consent

  16. Inability to comply with follow-up schedule due to a history of medical noncompliance, living a distance from the study center, or anticipated non-residence in the area for the length of time required for follow-up

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